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Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00489086
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : February 11, 2016
Last Update Posted : February 11, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UCSF Benioff Children’s Hospital Oakland

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplastic Syndrome
Intervention Drug: tazarotene
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tazarotene Cream
Hide Arm/Group Description This is a 36 month, multi-center, single arm, open label clinical study design
Period Title: Overall Study
Started 36
Completed 13 [1]
Not Completed 23
[1]
23 subjects completed 18 months
Arm/Group Title Tazarotene Cream
Hide Arm/Group Description This is a 36 month, multi-center, single arm, open label clinical study design
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
<=18 years
0
   0.0%
Between 18 and 65 years
36
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
53  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
16
  44.4%
Male
20
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
1.Primary Outcome
Title Complete Response Rate
Hide Description The primary endpoint used to evaluate tazarotene efficacy for BCC chemotherapy was the complete response (CR) rate, defined as the complete visible disappearance of a patient’s “target” lesion during the the 18 months of tazarotene application and its failure to recur during the ensuing 18-months. We defined surgical removal of a target lesion as a treatment failure. The primary endpoint was assessed based on intention to treat analysis such that any subject who underwent the baseline evaluation and applied at least 1 dose of tazarotene was included in the analysis. Drop-outs were considered non-responders. A priori treatment success for tazarotene was defined as a CR rate of at least 50%, and treatment failure was defined as a CR rate of 25% or less.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Tazarotene Cream
Hide Arm/Group Description:
This is a 36 month, multi-center, single arm, open label clinical study design
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: participants
2
2.Secondary Outcome
Title Time to Lesion Clearance
Hide Description [Not Specified]
Time Frame 36 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Time to Progression
Hide Description [Not Specified]
Time Frame 36 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Estimated Duration of Complete Response
Hide Description [Not Specified]
Time Frame 36 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Response at Treated Lesions
Hide Description [Not Specified]
Time Frame 36 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tazarotene Cream
Hide Arm/Group Description This is a 36 month, multi-center, single arm, open label clinical study design
All-Cause Mortality
Tazarotene Cream
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tazarotene Cream
Affected / at Risk (%)
Total   2/36 (5.56%) 
Ear and labyrinth disorders   
cellulitis and maxillary sinusitis †  1/36 (2.78%) 
Renal and urinary disorders   
prostate cancer diagnosis †  1/36 (2.78%) 
†
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Tazarotene Cream
Affected / at Risk (%)
Total   31/36 (86.11%) 
Skin and subcutaneous tissue disorders   
irritation †  6/36 (16.67%) 
dryness †  6/36 (16.67%) 
inflammation †  1/36 (2.78%) 
itching †  3/36 (8.33%) 
peeling †  4/36 (11.11%) 
edema †  1/36 (2.78%) 
rash †  4/36 (11.11%) 
erythema †  6/36 (16.67%) 
†
Indicates events were collected by systematic assessment
34 pts. were included in the analysis of the primary endpoint. 23 pts. completed 18 months (68%). Only 2 of 34 patients achieved complete resolution (CR = 5.9%). 13 pts. completed 36 month trial (first 18 months tazarotene, months 19-36 observation).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Raj Prasad
Organization: ChildrensHRCOakland
Phone: 510-450-7602 ext 7602
EMail: rprasad@chori.org
Layout table for additonal information
Responsible Party: UCSF Benioff Children’s Hospital Oakland
ClinicalTrials.gov Identifier: NCT00489086     History of Changes
Obsolete Identifiers: NCT00500643
Other Study ID Numbers: CDR0000551655
R01CA109584 ( U.S. NIH Grant/Contract )
P30CA082103 ( U.S. NIH Grant/Contract )
First Submitted: June 20, 2007
First Posted: June 21, 2007
Results First Submitted: July 31, 2013
Results First Posted: February 11, 2016
Last Update Posted: February 11, 2016